Opinion: STAT+: The FDA should embrace remote and automated drug inspection technology
While pharmaceutical regulatory authorities in other countries are employing creative ways like video-based remote inspections to fulfill their obligations to the public, the U.S. Food and Drug Administration remains committed to conventional on-site inspections. By September 2020, the Covid-19 pandemic had precipitated a virtual pause in drug inspections: Roughly 85% of inspections had been curbed within U.S. borders and 99.5% outside the country.
Inspecting manufacturing facilities is a vital part of drug approval and production, and backlogs can cause huge delays, creating drug shortages in the global supply chain and threatening another global health crisis. Inspections are a key tool the FDA uses to ensure that drug producers adhere to manufacturing and record-keeping requirements, which ensures the safety of drugs on the market. Drug producers cannot legally operate without passing initial or recurring inspections.
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